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FDA Approves New Form Of Self-Administered Female Birth ControlOn Friday, TherapeuticsMD Inc (NASDAQ: TXMD) announced FDA approval of the first-ever patient-controlled long-acting reversible vaginal birth control system. What Happened? The new birth control is the first of its kind and is likely to be classified as a “new chemical entity,” which would potentially grant TherapeuticsMD five years of patent exclusivity. “The U.S. contraceptive market is shifting toward long-acting solutions and we believe ANNOVERA represents an exciting new entrant for women and healthcare providers by providing the first woman-controlled, procedure-free, long-acting, reversible birth control product putting the woman in control of both her fertility and menstruation," said Dr. Brian Bernick, Co-Founder of TherapeuticsMD. What’s Next?

Fri, 10 Aug 2018 19:05:00 +0000

TherapeuticsMD Announces FDA Approval of ANNOVERA™ (Segesterone Acetate/Ethinyl Estradiol Vaginal System) for Birth ControlTherapeuticsMD, Inc. (TXMD), an innovative women’s healthcare company, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved ANNOVERA™ (segesterone acetate/ethinyl estradiol vaginal system), the first long-acting prescription birth control that is patient-controlled, procedure-free and reversible. The ANNOVERA contraceptive vaginal system is a small, soft flexible ring that prevents ovulation for an entire year (13 cycles) and can be inserted and removed by a woman at her discretion in repeated four-week cycles (remaining in place continuously for three weeks followed by removal for one week).

Thu, 09 Aug 2018 09:48:00 +0000

TherapeuticsMD Receives Bullish Note From Street on New Found Potential TherepeuticsMD (NYSE: TXMD), a commercial stage biopharma company focused on women’s health innovation, has seen massive stock price movement in the past few months as it goes through new developments in its service offering. Here we use TipRanks data to take a closer look at what Wall Street’s top analysts see in store for this surging stock over the next 12 months. The primary factor driving bullish sentiments from analysts is the company’s new product, Imvexxy.

TherapeuticsMD Announces Closing of its Underwritten Public Offering and Concurrent Registered Direct Offering of Common StockTherapeuticsMD, Inc. (TXMD) today announced the closing of its previously announced $65 million underwritten public offering of common stock, at a price to the public of $5.10 per share, and concurrent $20 million registered direct offering of common stock to a strategic investor at a price of $5.10 per share. In connection with the underwritten public offering, TherapeuticsMD granted the underwriters an option to purchase up to an additional 1,911,764 shares of common stock at the public offering price less the underwriting discount, which option was exercised in full and closed. TherapeuticsMD received net proceeds from the offerings of approximately $90.0 million, after deducting underwriting discounts and offering expenses payable by TherapeuticsMD.

TherapeuticsMD Announces Pricing of Its Underwritten Public Offering and Concurrent Registered Direct Offering for Aggregate Gross Proceeds of $85 MillionTherapeuticsMD, Inc. (TXMD) today announced the pricing of its previously announced $65 million underwritten public offering of common stock at a price to the public of $5.10 per share. In addition, TherapeuticsMD has granted to the underwriters of the underwritten public offering an option for a period of 30 days to purchase, at the public offering price less the underwriting discount, up to an additional 1,911,764 shares of common stock. The gross proceeds to TherapeuticsMD from the offerings are expected to be approximately $85 million, before deducting underwriting discounts, commissions and other offering expenses payable by TherapeuticsMD, assuming no exercise of the underwriters’ option to purchase additional shares of common stock.

Tue, 31 Jul 2018 20:15:00 +0000

TherapeuticsMD Licenses Population Council’s Novel Segesterone Acetate/ Ethinyl Estradiol One-Year Vaginal Contraceptive SystemTherapeuticsMD, Inc. (TXMD), an innovative women’s healthcare company, today announced that it has entered into an exclusive license agreement with the Population Council to commercialize its investigational segesterone acetate/ ethinyl estradiol one-year vaginal system for contraception in the United States (U.S.). The one-year vaginal contraceptive system is in the shape of a ring and combines a novel progestin, segesterone acetate (Nestorone®), with a widely used estrogen to prevent ovulation for an entire year (13 cycles). The New Drug Application (NDA) for the one-year vaginal contraceptive system is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date for the completion of the FDA’s review of the NDA of August 17, 2018.

Tue, 31 Jul 2018 20:13:00 +0000

Knight Therapeutics and TherapeuticsMD Announce Strategic PartnershipKnight Therapeutics Inc. (GUD.TO) (“Knight”), a Canadian specialty pharmaceutical company, and TherapeuticsMD, Inc. (TXMD), an innovative women’s healthcare company, today announced that they have entered into a licensing agreement that grants Knight the rights to commercialize TX-004HR and TX-001HR in Canada and Israel. TX-004HR is TherapeuticsMD’s FDA-approved product, marketed as Imvexxy™ (estradiol vaginal inserts) in the U.S., for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.

TherapeuticsMD to Report Second Quarter 2018 Financial Results on July 30, 2018TherapeuticsMD, Inc. (TXMD), an innovative women’s healthcare company, today announced that it will report its second quarter 2018 financial results on Monday, July 30, 2018, before the opening of the U.S. financial markets. Following the announcement, executive management will host a conference call and webcast at 8:30 a.m. ET on such date to discuss the Company’s financial results and provide a business update.

TherapeuticsMD Announces Draw Down of $75 Million Under Term Loan with MidCap FinancialTherapeuticsMD, Inc. (TXMD), an innovative women’s healthcare company, today announced that the company has completed the first draw down of $75 million under its previously announced $200 million term loan facility with MidCap Financial, managed by Apollo Capital Management, L.P. The Company intends to use the proceeds from the financing to support the commercial launch of its recently approved product, Imvexxy™ (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women.

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